| Clinical Trials and Drug Development |
| Source | Pharma-CAL-ogy |
| Versions Available | Windows |
| Programmer(s) | Michael Cunningham, Robert Foster, Alan Gibbs, Alan George, Graham Ogg and Cheryl Padagham |
| Summary | |
 Screen shot from the package |
The material is presented at undergraduate level and
encompasses the principles of new drug development, human experimentation,
clinical trials and measuring the effectiveness of therapy. The tutorial
elements may be used for stand - alone teaching. The simulation elements
are better used to achieve objectives which are defined by a tutor
and which utilise specific tasks integrated into course. After using
the package appropriately students should know and understand:
- the role of each of the pre-clinical processes of new drug development; - the role of each of the clinical phases of new drug development; - the considerations influencing the planning and conduct of clinical trials; and be able to summarise outcome data from clinical trial, test hypotheses comparing test and control limbs for efficacy and unwanted effects and make overall benefit/risk judgements. Help is given with statistical analysis and interpretation of
data from simulated clinical trials. Students are shown how to calculate
summary statistics, chi squared and other hypothesis test. It is
best if students copy their data into spreadsheet or statistics
package and use the tools available within that package. |
| Contents |
| Drug Discovery |
| Pre-clinical Processes of Drug Development |
| Clinical Processes of Drug Development |
| Clinical Trials |
| Simulations of Clinical Trials |
| System Requirements |
| The package is supplied on a CD-ROM Installation Disc and can be installed to a local hard disc or network drive. |